Portolano Cavallo

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5 Dec 22
The European Commission sends a Statement of Objection to a drug manufacturer accusing it of regulatory gaming and denigration of competitors in breach of Article 102 TFEU
On October 10, 2022, the European Commission sent a Statement of Objection to Teva accusing the company of denigrating a competing product and of “regulatory gaming” in management of the life cycle of its multiple sclerosis drug Capoxone, conduct deemed abusive pursuant to Article 102 of the Treaty on the Functioning of the European Union.
1 Sep 22
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
16 Nov 21
Draft competition bill: New rules for the healthcare sector?
On November 5, 2021, the Council of Ministers approved the draft law on competition. The Competition Bill is now under review by Parliament, which will discuss the draft in the coming weeks.
14 Sep 21
Pharmaceutical company liability in clinical trials: The italian supreme court’s latest decision
On April 20, 2021, the Italian Supreme Court dealt with a complex and much debated matter: pharmaceutical company liability for damages to a participant in a sponsored clinical trial.
12 Apr 21
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
3 Dec 20
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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